1.Discrepancy Between Approved Sites and Sites in Production:
Organizations typically submit backup sites to their application to serve in case there is a need to switch manufacturing sites. FDA SPL team has recently recommended only including active sites to the SPL file. However, if there is ever a need to move to a different site, this may cause confusion as far as updating information correctly for the back up sites. It is not certain if adding more sites may add to the PDUFA user fees. We will have to ask PDUFA group within FDA what constitutes a user fee. We will also have to ask SPL group if all sites can be included to avoid future confusion.
2. Combination products: Many organizations have combination products that utilize more than one final product. If an organiztion has a kit to drug list, it should contact the SPL@fda.hhs.gov e-mail address to get assistance. Some of the kits listed on DailyMed are incorrect and will be adjusted in the future, so they should not be used as examples. If FDA is not contacted for assistance, and a company decides to submit on their own, there is a possibility that the company will get validation errors and may work on a trial and error basis. Additionally, there is a webinar that will be for combination products at the end of the month. Check the Wiki training page for details on future webinars.
3. DUNS number issues:
DUNs numbers are a way to validate site information for establishments, labelers, etc. Some are finding discrepancies with their DUNS numbers and also with their FEI numbers on the Establishment directory.
D&B has stated that a DUNS number is never retired, so if a company goes out of business or closes an establishment, the DUNS number is still in existence.
There is confusion within reimbursement agencies, especially outside the U.S. with establishments with names differing from the parent company. A "doing business as (DBA)" section used to alleviate this issue in the paper format FDA Form 2656, but now the only alternative to this is to list the DBAs within the DUNS numbers. This may not be "official" enough for these reimbursement agencies. Follow will be needed.
4. Next meeting - June 24, 2009 at 2 PM Eastern Time.
Organizations typically submit backup sites to their application to serve in case there is a need to switch manufacturing sites. FDA SPL team has recently recommended only including active sites to the SPL file. However, if there is ever a need to move to a different site, this may cause confusion as far as updating information correctly for the back up sites. It is not certain if adding more sites may add to the PDUFA user fees. We will have to ask PDUFA group within FDA what constitutes a user fee. We will also have to ask SPL group if all sites can be included to avoid future confusion.
2. Combination products:
Many organizations have combination products that utilize more than one final product. If an organiztion has a kit to drug list, it should contact the SPL@fda.hhs.gov e-mail address to get assistance. Some of the kits listed on DailyMed are incorrect and will be adjusted in the future, so they should not be used as examples. If FDA is not contacted for assistance, and a company decides to submit on their own, there is a possibility that the company will get validation errors and may work on a trial and error basis. Additionally, there is a webinar that will be for combination products at the end of the month. Check the Wiki training page for details on future webinars.
3. DUNS number issues:
DUNs numbers are a way to validate site information for establishments, labelers, etc. Some are finding discrepancies with their DUNS numbers and also with their FEI numbers on the Establishment directory.
D&B has stated that a DUNS number is never retired, so if a company goes out of business or closes an establishment, the DUNS number is still in existence.
There is confusion within reimbursement agencies, especially outside the U.S. with establishments with names differing from the parent company. A "doing business as (DBA)" section used to alleviate this issue in the paper format FDA Form 2656, but now the only alternative to this is to list the DBAs within the DUNS numbers. This may not be "official" enough for these reimbursement agencies. Follow will be needed.
4. Next meeting - June 24, 2009 at 2 PM Eastern Time.